Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Monograph for OTC Bronchodilator Drug Products

Samenvatting

The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) bronchodilator drug products to remove pressurized metered-dose aerosol container dosage forms for the ingredients epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. This action is being taken because the OTC marketing of such drug products will require an approved application containing certain information not required by the monograph. The agency is also proposing to amend the regulation that lists nonmonograph active ingredients to add any ingredient(s) in a pressurized metered-dose aerosol container for OTC bronchodilator drug products. This proposal is part of the ongoing review of OTC drug products conducted by FDA.